Safety and Immunogenicity of Two 0.25 mL or 0.5 mL Doses of Two Different Influenza Vaccines in Healthy Children Aged 6 to <60 Months

Phase 2

Completed

• Conditions: Influenza
• Interventions: Biological: Influenza Trivalent Inactivated vaccines Novartis; Biological: Influenza Trivalent Inactivated vaccines

• Registration Number: NCT00649883
• Lead Sponsor: Novartis

Brief Summary

This a multicenter phase II trial will evaluate safety and immunogenicity of two 0.25 mL or 0.5 mL doses of investigational influenza vaccine and active control influenza vaccine in healthy children aged 6 to \<60 months.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-03-25
• Study First Submitted QC: 2008-03-27
• Primary Completion: 2008-04
• Study First Posted: 2008-04-01
• Study Completion: 2008-10
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-05
• Last Update Posted: 2017-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

• Children of 6 to <60 months of age, whose parents/legal guardians have given written informed consent prior to study entry.
• In good health as determined by: medical history, physical examination, clinical judgment of the investigator.
• Able to comply with all study procedure

Exclusion Criteria

• Any serious disease, such as: cancer,autoimmune disease (including rheumatoid arthritis), diabetes mellitus, chronic pulmonary disease, acute or progressive hepatic and renal disease, acute or progressive neurological or neuromuscular disease;
• History of any anaphylaxis or serious reaction following administration of vaccine, or hypersensitivity to eggs, egg protein, chicken feathers, influenza viral protein, or any other vaccine component, chemically related substance, or component of the potential packaging materials;
• Known or suspected impairment/alteration of immune function, including: immunosuppressive therapy, cancer chemotherapy, receipt of immunostimulants within 60 days prior to Visit 1, receipt of parenteral immunoglobulin known HIV infection or HIV-related disease;
• Bleeding diathesis;
• Surgery planned during the study period;
• Receipt of another investigational agent within 90 days
• Laboratory-confirmed influenza disease within 6 months prior to Visit 1;
• Ever received two doses of an influenza vaccine before the study
• Receipt of an influenza vaccine within 6 months prior to Visit 1;
• Experienced a temperature 38.0°C within 3 days prior to Visit 1

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Influenza Trivalent Inactivated vaccines Novartis	-
2	Influenza Trivalent Inactivated vaccines	-

Primary Outcome Measures

Name	Time	Method
To evaluate the safety and tolerability of one and two doses of investigational vaccines or active control influenza vaccine in unprimed healthy children aged 6 months to <36 months.	211 days

Secondary Outcome Measures

Name	Time	Method
To evaluate the immunogenicity of two doses of investigational influenza vaccine or active control influenza vaccines, as measured by HI assay in children aged 36 to <60 months.	211 days

Trial Locations

Locations (5)

Dr. Carlos Fernando Grazioso Aragón; 🇬🇹 Guatemala City, Guatemala

Centro Clínico La Quinta; 🇬🇹 Guatemala City, Guatemala

Clínicas Dr. Rafael Montiel; 🇬🇹 Guatemala City, Guatemala

Fundación Pediátrica Guatemalteca; 🇬🇹 Guatemala City, Guatemala

Hospital Infantil de Infectologia y rehabilitacion; 🇬🇹 Guatemala City, Guatemala